MAUDE Adverse Event Report: GREATBATCH MEDICAL ACETABULAR REAMER SHELL 47MM

Model Number 00-1206-090-47

Device Problems Monitor failure (1407); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

It was reported the surgeon repeatedly complains the reamers are too dull to cut through bone and has to exert tremendous pressure to get the proper fit for implants.Another set of reamers was used to complete the procedure.It is unknown if there were adverse events as a result of the malfunction.

Manufacturer Narrative

The device was returned to greatbatch medical and evaluation is in process.Once greatbatch medical completes the investigation, a supplemental medwatch 3500a form will be submitted.Complaint information was provided by zimmer.

Manufacturer Narrative

Complaint sample was returned for evaluation and the reported event was not confirmed.A manufacturing review was completed and no discrepancies were found.No further investigation required.

• Brand Name: ACETABULAR REAMER SHELL 47MM
• Type of Device: REAMER SHELL
• Manufacturer (Section D): GREATBATCH MEDICAL ; tijuana, baja california ; MX
• Manufacturer (Section G): GREATBATCH MEDICAL MEXICO (GMM)
• Manufacturer Contact: noe rivera ; 4545 kroemer rd.; fort wayne, IN 46818 ; 2607557490
• MDR Report Key: 4737169
• MDR Text Key: 19721991
• Report Number: 3007882731-2015-00002
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1206-090-47
• Device Catalogue Number: T2768
• Device Lot Number: 56559046
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1